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All photos courtesy of Clinical Trials Ontario
Clinical Trials Ontario:
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cultivating Ontario’s clinical trials landscape
Getting a multi-site clinical trial approved in Ontario can be a time-consuming and headacheinducing task. Currently, multisite clinical trials need to be approved at every site participating in the clinical trial, which may be between five to 20 sites in Ontario alone.
Moreover, the reviews from independent institutional ethics committees may have different requirements for approval that can be inconsistent with one another. An inefficient approval process is in part the reason why Ontario is experiencing a drop in the number of global pharmaceutical companies basing their trials in Ontario.
In a move to stop the clinical trial dispersion, a new non-profit organization Clinical Trials Ontario (CTO) has been established to make Ontario a more attractive jurisdiction for drug development, by reshaping the province’s clinical trials infrastructure landscape.
With an end goal of making Ontario more competitive globally, CTO aims to streamline the ethics review process and the contract approval for industry-driven multi-site trials, without compromising the province’s ethical standards. CTO also intends to work with industry, research and government partners to gain access to global clinical trial leadership, as well as launching an initiative to explain the potential advantages of clinical trials to the public, as well as patients and their families.
“The idea behind Clinical Trials Ontario is to modernize and reform the clinical trials infrastructure associated with getting initial approval to conduct a clinical trial, and maintaining ongoing ethics approval while ensuring the highest standards of research ethics” says CTO’s Interim Executive Director, Dr. Ron Heslegrave. “We’re fundamentally changing the process.”
The redesign is much-welcomed by researchers and companies alike. It is also much-needed, as Ontario has experienced a 10 to 12 per cent annual loss of global clinical trial activity in recent years.
As pharmaceutical companies veer towards countries that offer larger tax breaks for clinical trials, or maintain quality at cheaper costs in developing nations, Ontario is losing its appeal as a drug development location.
To combat this, CTO was launched at the 2012 BIO International Convention, through the Ministry of Economic Development and Innovation (MEDI). The not-for-profit is a part of Ontario’s Life Sciences Commercialization Strategy. As an independent corporation, CTO is currently receiving funds from the Ontario provincial government, with hopes to eventually be financially selfsustaining.
Although the organization was recently launched in June 2012, CTO has been in the works for a number of years. From 2008 to 2009, the Ministry of Research and Innovation and the Ministry of Economic Development and Trade, which became MEDI in 2011, set up two task forces to look at the clinical trials crisis. For Dr. Heslegrave, who was on the second of the two task forces, the main issue was improving Ontario’s competitiveness through superior efficiencies in infrastructure without reducing the safety for patients.
“We had six recommendations to the Ontario Government - MRI at that point - with regard to how we can improve our competitiveness in the clinical trials area, including things like the need for such infrastructure reform. The ministry accepted three of those recommendations in their 2010 Commercialization Strategy for Ontario.”
From the commercialization strategy, a clinical trials stakeholder association was formed to create CTO. With his wealth of experience in the field obtained by chairing various boards, including the University Health Network, the Ontario Cancer Research Ethics Board, and leading the Harmonization Task Force for the Toronto Academic Health Science Committee, as well as working with various provincial, national and international initiatives, Dr. Heslegrave was selected to lead this new initiative.
He explains how CTO put together a Strategic Plan to streamline the clinical trials process that will make the processes more uniform and efficient, while preserving safety and maintaining the highest standards for ethical oversight of clinical trials – a plan approved by the Ministry of Economic Development and Innovation which has led to three years of funding. “Right now, we have many voices in Ontario,” says Dr. Heslegrave. “We want Clinical Trials Ontario to be a single hub for this increased efficiency and a single voice for Ontario at the national level.”
The organization has three pillars in place to help the province become more alluring for drug investment. The focus is on making the system more efficient. Currently for multi-site trials in Ontario, pharmaceutical companies must go throw an approval process for each trial site, which can fast become a headache.
“In a five site multi-site study in Ontario, you have five different ethics boards that can have five different opinions,” says Dr. Heslegrave. “But they may be contradictory to one another, so it becomes very time consuming to sort this out and sometimes the differences between boards cannot be resolved. It’s very inefficient and costly.”
Whether two trial institutions or 20, companies need approval from each institution, which Dr. Heslegrave says, is an outdated system.
“This is the way clinical trials have been done for years, and it made sense when research was primarily conducted at a single site. It doesn’t make sense in the way clinical trials are conducted globally now, because most trials have multiple sites all over the world, and you need approval from each site before you can actually start to run the trial at that site. Inevitably, sites that are slower to approve the study may end up not being able to participate in the trial due to the competitive nature of patient recruitment across the entire study globally.”
Other jurisdictions like the US and Europe are moving towards reforming their system. Ontario needs to do the same but better.
Streamlining the research ethics approval process to a single review in Ontario, along with other administrative platforms, is strategic pillar one for CTO. Its second pillar looks at collaborating with industry, government and investigators to market Ontario to the global headquarters of companies.
“Decisions on where to place clinical trials globally are made by global headquarters,” explains Dr. Heslegrave. “Local company subsidiaries in different countries, like Canada, must lobby their global decision makers to attract clinical trial sites to their jurisdiction.”
“In other words, Pharma Company X (Canadian division) would be lobbying Pharma Company X Global to try to obtain global approval for a number of trial sites in Canada and Ontario. To be successful, local subsidiaries need to sell the value of the local jurisdiction. CTO intends to reform the clinical trials infrastructure to be more competitive in this regard.”
From global to local, CTO’s final pillar targets increasing patient recruitment, by getting Ontarians engaged in trials and educating the public on the health and social benefits of participating in clinical trials.
“Canada has been a poor recruiter into clinical trials for a number of reasons,” says Dr. Heslegrave. “One of those reasons is that in Canada the public does not fully understand the value associated with clinical trials.”
While still in its infancy, Clinical Trials Ontario is working with the various sectors of Ontario’s life sciences, from biotechnology and medical devices to pharma, as well as with business leaders and academics, to improve the health of patients in Ontario.
“We encourage Ontarians to think positively about clinical trials in order to gain access to innovative and new therapy, and to help us move towards solutions for improved therapies for many of the diseases that haunt us every day.”
We wish them best of luck, in helping fight disease, and putting Ontario back on the drug development map.
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